NCT07467980 Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension
| NCT ID | NCT07467980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Anastomotic Leak Rectum |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-03-16 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anastomosis refers to the surgical connection between two segments of the bowel, typically performed during colon and rectal surgeries to restore the continuity of the digestive tract after a section has been removed. It is necessary that the ends of the tissue at the anastomotic site are healthy (and capable of healing properly) as this will prevent dreaded complications like anastomotic leaks or strictures which can occur in almost a fifth of patients leading to increased hospital length of stay, costs, and mortality. Currently, the most widely used method for assessing tissue viability during anastomosis is indocyanine green fluorescence angiography (ICG-FA). This technique involves injecting a fluorescent dye (indocyanine green) into the bloodstream, which highlights blood flow and tissue perfusion under a special camera. However, ICG-FA has limitations due to allergies and reliability due to the dye's rapid disappearance from the bloodstream. Additionally, the dye cannot be administered repeatedly. This study explores a new method of measuring tissue oxygenation by evaluating mucosal oxygen saturation (StO2) as an alternative to ICG-FA. By evaluating StO2 levels, the research aims to provide a more reliable and repeatable way to assess tissue viability without the drawbacks of using fluorescent dyes. Secondly, any blood supply interruption to the bowel will first lead to mucosal ischemia, which can potentially be reliably captured by measuring mucosal StO2 levels only. In this single-center prospective single-arm study, we will evaluate whether mucosal StO2 levels are associated with or can predict anastomotic complications. This study will not involve any intervention that would affect the standard of care.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years). * Undergoing a colo-rectal anastomosis. * Patients who consent to study participation Exclusion Criteria: * Patients undergoing a revision surgery. * Participants with missing data. * Patients who do not undergo intraoperative ICG-FA and StO2 endoscopic imaging promptly after the formation of a viable anastomosis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07467980 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anastomotic Leak Rectum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07467980 currently recruiting?
Yes, NCT07467980 is actively recruiting participants. Contact the research team at aimal.khan@vumc.org for enrollment information.
Where is the NCT07467980 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07467980 clinical trial?
NCT07467980 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 80 participants.